STERILE CATHERIZATION PROCEDURE TRAYS

STERILE CATHERIZATION PROCEDURE TRAYS is an FDA 510(k)-cleared medical device (K830359) manufactured by Welcon, Inc.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 16, 1983. Regulation: 8.